PACKAGE LEAFLET: INFORMATION FOR THE USER. Buplex Rx 400 mg film-coated tablets. Ibuprofen

Transcription

1 PACKAGE LEAFLET: INFORMATION FOR THE USER Buplex Rx 400 mg film-coated tablets Ibuprofen Read all of this leaflet carefully before you start taking this medicine. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What Buplex Rx is and what it is used for 2. Before you take Buplex Rx 3. How to take Buplex Rx 4. Possible side effects 5. How to store Buplex Rx 6. Further information 1. WHAT BUPLEX RX IS AND WHAT IT IS USED FOR Buplex Rx belongs to a group of medicines called NSAID (non-steroidal anti-inflammatory drugs) which work by reducing pain, inflammation and fever. Buplex Rx is used to provide relief from mild to moderate pain such as headache, including migraine headache, dental pain, period pain and fever. If you are over 12 years of age your doctor may also prescribe this or higher doses for the treatment of rheumatoid arthritis, osteoarthritis, or other inflammatory or painful joint conditions, as well as for inflammatory and painful conditions of soft tissues such as muscles. 2. BEFORE YOU TAKE BUPLEX RX Do not take Buplex Rx - if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of Buplex Rx. - if you have had allergic reactions such as asthma, runny nose, itchy skin rash or swelling of the lips, face, tongue, or throat after you have taken medicines containing acetylsalicylic acid (such as aspirin) or other drugs for pain and inflammation (NSAIDs). - if you have suffered from an ulcer or bleeding in the stomach or small intestine (duodenum) related to previous use of drugs for pain and inflammation (NSAIDs) - if you are suffering from an ulcer or bleeding in the stomach or small intestine (duodenum) or if you have had two or more of these episodes in the past - if you suffer from severe liver, kidney or heart problems (including coronary heart disease) - if you are in the last 3 months of pregnancy - if you are suffering from significant dehydration (caused by vomiting, diarrhoea or insufficient fluid intake) - if you have any active bleeding (including in the brain) - if you suffer from a condition of unknown origin resulting in abnormal formation of blood cells - children younger than 6 years. 11

2 Take special care with Buplex Rx - if you have Systemic Lupus erythematosus (SLE) or other autoimmune diseases - if you have inherited a disorder of the red blood pigment haemoglobin (porphyria) - if you have chronic inflammatory intestinal diseases such as inflammation of the colon with ulcers (ulcerative colitis), inflammation affecting the digestive tract (Crohn s disease) or other stomach or intestinal diseases - if you have disturbances in the formation of blood cells - if you have problems with normal blood clotting mechanism - if you suffer from allergies, hay fever, asthma, chronic swelling of nasal mucosa, sinuses, adenoids, or chronic obstructive affections of the respiratory tract because the risk for developing narrowing of the airways with difficulty in breathing (bronchospasm) is greater - if you suffer from circulation problems in the arteries of your arms or legs - if you have liver, kidney, heart problems or high blood pressure - if you have just had major surgery - if you are in the first six months of pregnancy - if you are breast-feeding Elderly If you are elderly you will be more prone to side effects, especially bleeding and perforation in the digestive tract, which may be fatal. Ulcers, perforation and bleeding in the stomach or intestines If you have earlier had an ulcer in the stomach or intestines, especially if this has been complicated by perforation or accompanied by bleeding, you should look out for any unusual symptoms in the abdomen, and report them at once to your doctor, especially if these symptoms occur at the beginning of treatment. This is because the risk for bleeding or ulceration of the digestive tract is higher in this case, especially in elderly patients. If bleeding or ulceration of the digestive tract occurs, the treatment has to be stopped. Bleeding, ulceration or perforation in the stomach or intestines may occur without any warning signs even in patients who have never had such problems before. It may also be fatal. The risk of ulcers, perforation or bleeding in the stomach or intestines generally increases with higher doses of ibuprofen. The risk also increases if certain other medicines are taken at the same time as ibuprofen (see Taking other medicines, below). Skin reactions You should stop taking Buplex Rx with the first sign of skin rash, lesions of the mucous membranes or other signs of allergy since this can be the first sign of serious skin reactions (exfoliative dermatitis, erythema multiforme, Steven-Johnson s syndrome, Lyell s syndrome), sometimes with fatal outcome. The highest risk of these reactions is in the first month of treatment. Effects on the heart and brain Medicines such as Buplex Rx may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. If you have heart problems, previous stroke or think that you might be at a risk of these conditions (for example if you have high blood pressure, diabetes, or high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist. Effects on the kidneys Ibuprofen may cause problems with kidney function even in patients who have not had kidney problems before. This may result in swelling of the legs and may even lead to heart failure or high blood pressure in predisposed individuals. 12

3 Ibuprofen may cause kidney damage especially in patients who already have kidney, heart or liver problems, or are taking diuretics or ACE inhibitors, as well as in the elderly. Stopping Ibuprofen however generally leads to recovery. Other precautions During long-term, high-dose use of pain killers headache may occur which should not be treated with high doses of this medicine. The habitual use of painkillers may cause permanent damage to the kidneys and a risk of kidney failure. Ibuprofen may hide the symptoms or signs of an infection (fever, pain and swelling) and temporarily prolong bleeding time. Buplex Rx may decrease your chance of becoming pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. The side effects of Buplex Rx may be increased if certain medicines are taken at the same time. On the other hand, Buplex Rx may increase or decrease the effect of other medicines or increase their side effects when taken at the same time. Please tell your doctor or pharmacist if you are taking: - other NSAIDs - acetylsalicylic acid (Aspirin) - anticoagulants (against clotting) such as warfarin or heparin - platelet aggregation inhibitors (against clotting) such as ticlopidin or clopidogrel - methotrexate (used to treat cancer and auto-immune diseases) - digoxin (for treatment of various heart conditions) - phenytoin (used in prevention of the occurrence of epileptic seizures) - lithium (used to treat depression and mania) - diuretics (water tablets), including potassium-sparing diuretics - antihypertensives (for treating high blood pressure) such as: ACE-inhibitors, e.g. captopril beta-receptor blocking medicines angiotensin II antagonists - cholestyramine (used in the treatment of high cholesterol) - aminoglycosides (medicines against certain types of bacteria) - SSRIs (medicines against depression) such as paroxetin, sertralin, citalopram - moclobemide (RIMA a medicine to treat depressive illness or social phobia) - ciclosporine, tacrolimus (for immuno-suppression after organ transplant) - zidovudine or ritanovir (used to treat patients with HIV) - mifepristone - probenecid or sulfinpyrazone (for treating gout) - quinolone antibiotics - sulphonylureas (to treat type 2 diabetes) - corticosteroids (used against inflammations) - bisphosphonates (used in osteoporosis, Paget s disease and to reduce high blood calcium levels) - oxpentifylline ((pentoxifylline) used in the treatment of circulatory disease of the arteries of the legs or arms) - baclofen (a muscle relaxant) Taking Buplex Rx with food and drink You should swallow Buplex Rx with a glass of water during or after a meal. 13

4 Avoid alcohol since it may enhance the side effects of Buplex Rx, especially those affecting the stomach, intestines or brain. Pregnancy and breast-feeding Ask your doctor or pharmacist for advice before taking any medicine. Ibuprofen must not be taken in the last 3 months of pregnancy since it may cause major heart, lung and kidney disorders in the unborn child. If used at the end of pregnancy, it may cause bleeding tendencies in both mother and child and weaken the strength of uterine contractions delaying the onset of delivery. Treatment during the first 6 months of pregnancy will only be prescribed by your doctor if clearly necessary. Ibuprofen may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant. Ibuprofen appears in breast milk in a very small amount and breastfeeding will usually not need to be stopped during short-term treatments. If, however, longer treatment is prescribed, early weaning should be considered. Driving and using machines Ibuprofen generally has no adverse effects on the ability to drive or operate machinery. However since at high dosage side effects such as fatigue, somnolence, vertigo (reported as common) and visual disturbances (reported as uncommon) may be experienced, the ability to drive a car or operate machinery may be impaired in individual cases. This effect is potentiated by simultaneous consumption of alcohol. 3. HOW TO TAKE BUPLEX RX Always take Buplex Rx exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms. The ibuprofen dose depends on the patient s age and body weight. The maximum single daily dose for adults should not be greater than 800 mg of ibuprofen (2 tablets).the usual dose is: Mild to moderate pain and fever Adults and adolescents older than 12 years ( 40 kg): ½-1 tablet given as a single dose or 3-4 times a day with an interval of 4 to 6 hours. The dosage in migraine headache should be: 1 tablet given as a single dose, if necessary 1 tablet with intervals of 4 to 6 hours. The maximum daily dose should not exceed 3 tablets (1200 mg). Children 6-12 years (>20 kg): Other preparations may be more suitable for this age group. Your doctor will advise you accordingly. Children 6-9 years (20-29 kg): ½ tablet 1-3 times a day with intervals of 4 to 6 hours as required. The maximum number of tablets should not exceed 1½ tablet in one day. Children years (30-40 kg): ½ tablet 1-4 times a day with intervals of 4 to 6 hours as required. The maximum number of tablets should not exceed 2 tablets in one day. Period pain Adults and adolescents over 12 years of age: ½-1 tablet 1-3 times a day, with an interval of 4-6 hours as needed. The maximum daily dose should not be more than 3 tablets (1200 mg). Rheumatic diseases Adults: 14

5 The usual dose is 1-1½ tablet 3 times a day. Lower doses may be prescribed by your doctor. Due to the severity of your condition, the doctor may increase your medication to a maximum of 6 tablets (2400 mg) daily, taken in 3 or 4 divided doses. Adolescents over 12 years of age: The recommended dose is 20 mg/kg to a maximum of 40 mg/kg body weight daily in 3 to 4 divided doses. Your doctor will advise you accordingly. The tablet should be swallowed with a glass of water during or after a meal. For the ease of swallowing or adjusting of doses the tablets can be divided in equal halves. Elderly If you are elderly you will be more prone to side effects, especially bleeding and perforation in the digestive tract, which may be fatal. Your doctor will advise you accordingly. Reduced kidney or liver function If you suffer from reduced kidney or liver function, your doctor will advise you accordingly. If you take more Buplex Rx than you should If you take more Buplex Rx than you should, contact a doctor, emergency room or pharmacy. The symptoms of overdose may be: nausea, vomiting and stomach pain or diarrhoea. A buzzing in the ears, headache, dizziness, vertigo and bleeding from the stomach or intestines may also occur. In more serious cases of overdose, drowsiness, excitation, disorientation, coma, convulsions, cramps (especially in children), blurred vision and eye problems, kidney failure, liver damage, low blood pressure, reduced respiration, bluish discolouration of lips, tongue and fingers, and increased bleeding tendency may all occur. Worsening of asthma in asthmatics can also occur. If you forget to take Buplex Rx If you forget to take a dose, take it as soon as you can, except if there is less than four hours remaining until the time for the next dose. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this product, ask your doctor or pharmacist. 4. POSSIBLE SIDE EFFECTS Like all medicines, Buplex Rx can cause side effects, although not everybody gets them. Undesirable effects are more likely with higher doses and longer duration of treatment. Medicines such as Buplex Rx may be associated with a small increased risk of heart attack (myocardial infraction) or stroke. Water retention (oedema), high blood pressure and heart failure have been reported in association with NSAIDs. The side effects are stated according to the frequency they occur. The following convention has been used: Very common: affects more than 1 in 10 users Common: affects 1 to 10 in 100 users Uncommon: affects 1 to 10 in 1,000 users Rare: affects 1 to 10 in 10,000 users Very rare: affects less than 1 user in 10,000 users Not known: frequency cannot be estimated from the available data The following side effects are important and will require immediate action if you experience them. You should stop taking Buplex Rx and see your doctor immediately if the following symptoms occur: 15

6 Common: black tarry stools or blood-stained vomit (digestive tract ulcer with bleeding) Very rare: swelling of the face, tongue or throat (larynx) which can cause great difficulty in breathing (angioedema), rapid heartbeat, severe fall in blood pressure or life threatening shock a sudden allergic reaction with shortness of breath, wheezing and drop of blood pressure severe rash with blisters on the skin especially on the legs, arms, hands and feet which can also involve the face and lips (erythema multiforme, Stevens-Johnson s syndrome). This can get even more severe, the blisters get larger and spread out and parts of the skin may slough off (Lyell s syndrome). There may also be severe infection with destruction (necrosis) of skin, subcutaneous tissue and muscle You should stop taking the medicine and contact your doctor as soon as possible if you develop the following side effects: Very common: heartburn, abdominal pain, indigestion Uncommon: blurred vision or other eye problems such as sensitivity to light hypersensitivity reactions such as skin rash, itching, asthma attacks (sometimes with low blood pressure) Rare: vision loss Very rare: sudden filling of lungs with water resulting in difficulty to breathe, high blood pressure, water retention and weight gain Other possible side effects with Buplex Rx are: Very common: Disturbances in the digestive tract, such as diarrhoea, feeling sick, vomiting, wind, constipation Common: Digestive tract ulcer with or without perforation Bowel inflammation and worsening of inflammation of the colon (colitis) and digestive tract (Crohn s disease) and complications of diverticula of the large bowel (perforation or fistula) Microscopic bleeding from the intestine which may result in anemia Mouth ulcers and inflammation Headache, sleepiness, vertigo, dizziness, fatigue, agitation, insomnia and irritability Uncommon: Inflammation of the stomach lining Kidney problems including development of oedema, inflammation of the kidneys and kidney failure Runny nose Difficulty breathing (bronchospasm) Rare: Depression, confusion, hallucinations Lupus erythematosus syndrome Increase of blood urea nitrogen and other liver enzymes, decrease in haemoglobin and haematocrit values, inhibition of platelet aggregation and prolonged bleeding time, decrease serum calcium and increase in serum uric acid values of Very rare: Unpleasant awareness of heart beat, heart failure, heart attack or high blood pressure 16

7 Disorders of blood cell formation (with symptoms like: fever, sore throat, surface mouth ulcers, flulike symptoms, severe fatigue, nasal and skin bleeding) Ringing or buzzing in the ears Inflammation of the oesophagus or pancreas Narrowing of the bowel Acute inflammation of the liver, yellowish discolouration of the skin or whites of the eyes, liver dysfunction, damage or failure Inflammation of the brain membrane (without bacterial infection) Damage of the kidney tissue Hair loss Buplex Rx may cause a reduction in the number of white blood cells and your resistance to infection may be decreased. If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately. A blood test will be taken to check possible reduction of white blood cells (agranulocytosis). It is important to inform your doctor about your medicine. During treatment with ibuprofen, some cases of meningitis (presenting as stiff neck, headache, nausea, vomiting, fever or disorientation) have been observed in patients with existing autoimmune disorders such as systemic lupus erythematosus or mixed connective tissue disease. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. 5. HOW TO STORE Buplex Rx Keep out of the reach and sight of children. Do not use Buplex Rx after the expiry date which is stated on the packs. The expiry date refers to the last day of that month. This medicinal product does not require any special storage conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment. 6. FURTHER INFORMATION What Buplex Rx contains - The active substance is ibuprofen. Each film-coated tablet contains 400 mg ibuprofen. - The other ingredients are: Tablet core: cellulose, microcrystalline, silica, colloidal anhydrous, hydroxypropylcellulose, sodium laurylsulfate, croscarmellose sodium, talc Film coating (Opadry (white) 06B28499): hypromellose, macrogol 400, titanium dioxide (E171). What Buplex Rx looks like and contents of the pack Film-coated tablets. White, oval, biconvex film-coated tablets with a score on one face. The tablets can be divided into equal halves. Pack sizes: 17

8 Blisters: 6, 10, 12, 20, 24, 30, 50, 60, 90, 100 and 250 film-coated tablets. Tablet containers: 10, 20, 30, 50, 100 and 250 film-coated tablets. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Actavis Group PTC ehf, Reykjavikurvegi 76-78, 220 Hafnarfjordur, Iceland Manufacturer Actavis UK Limited Whiddon Valley Barnstaple North Devon EX32 8NS, United Kingdom or Balkanpharma Dupnitsa AD 3, Samokovsko Shosse Str Dupnitsa Bulgaria or PharmaPack International B.V., Bleiswijkseweg 51, 2712 PB Zoetermeer, The Netherlands This medicinal product is authorised in the Member States of the EEA under the following names: Malta: Austria: Belgium: Bulgaria; Czech Republic: Denmark: Estonia: Greece: Finland: Ireland: Iceland: Lithuania: Latvia: Netherlands: Norway: Poland: Portugal: Romania: Sweden: Slovakia: Ibuprofen Actavis 400 mg; Ibuprofen Actavis 400 mg Filmtabletten; Ibuprofen Actavis 400 mg filmomhulde tabletten; Ibuprofen Actavis; Ibuprofen Actavis 400 mg; Ifenin; Ibuprofen Actavis 400 mg; Ibuprofen / Actavis; Ibuprofen Actavis 400 mg tabletti, kalvopäällysteinen; Buplex Rx 400 mg Film-coated tablets; Íbúfen; Ibuprofen Actavis 400 mg plėvele dengtos tabletės; Ibuprofen Actavis 400 mg apvalkotās tabletes; Ibuprofen Actavis 400 mg; Ibuprofen Actavis; Ibuprofen Actavis; Ibuprofeno Actavis; Ibuprofen Actavis 400 mg comprimate filmate; Ibuprofen Actavis; Ibuprofen Actavis 400 mg 18

9 This leaflet was last approved in mm/yyyy 19